Treatment of Cannabis Use Disorder Among Adults With Comorbid Attention-Deficit/Hyperactivity Disorder

NCT02803229 | Completed Phase 2 Results DMC

• 2 other identifiers: 7280U54DA037842-01
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed protocol is a double-blind, placebo-controlled outpatient study of the safety and benefit of Extended-release mixed amphetamine salt (Adderall-XR, MAS-XR) in the treatment of individuals with Cannabis Use Disorder (CUD) and Attention-deficit/Hyperactivity Disorder (ADHD). The investigators plan to enroll 50 and randomize 40 of these patients in the trial. The primary objective of the study is to determine the efficacy of MAS-XR in promoting cannabis abstinence among individuals with CUD and in promoting a decrease of ADHD symptoms.

Conditions

Cannabis Use Disorder; Attention-deficit/Hyperactivity Disorder

Outcome Measures

Primary Outcomes (2)

• Marijuana Abstinence

  Number of participants who achieve abstinence from marijuana during the last two weeks of the trial as recorded by the Timeline Followback method and confirmed by urine toxicology.

  Change from baseline compared to last 2 weeks of the 12 week study on maintained dose (weeks 10 and 11 for completers) or last 2 weeks of participants' participation during the study for participants who drop out of the study before weeks 10 and 11

• Reduction in ADHD Symptoms

  The primary ADHD outcome measure will be the number of individuals who achieve at least a 30% reduction in symptom severity as measured by the Adult ADHD Interview Rating Scale (AISRS).

  Change from baseline compared to last week of trial on maintained dose during the 12 week trial (week 11 for completers) or last week of participants' participation during the 12 week trial for those who drop out of study prior to week 11.

Study Arms (2)

Placebo

PLACEBO COMPARATOR

matched Placebo arm

Drug: Matched placebo

Adderall-XR

EXPERIMENTAL

Adderall-XR (MAS-XR) 80 mg/day maximum maintenance dose

Drug: Adderall-XR

Interventions

Adderall-XR DRUG

Also known as: Extended-release mixed amphetamine salt

Adderall-XR

Matched placebo DRUG

matched placebo provided for placebo arm

Also known as: placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals who meet criteria for cannabis use disorder (CUD) and report that marijuana is their primary drug of abuse
• Individuals must report using marijuana at least 5 days a week over the past 28 days and have a positive urine test for tetrahydrocannabinol (THC) on the day of study entry
• Individuals must meet Diagnostic and Statistical Manual 5th ed. (DSM-5) criteria for adult ADHD
• Individuals who score \> 22 on the adult ADHD Investigator Symptom Rating Scale (AISRS)
• Individuals between the ages of 18-65 capable of giving informed consent and capable of complying with study procedures
• Women of child-bearing age will be included if they: a) are not pregnant, b) agree to use an effective method of contraception, c) agree not to become pregnant during the study and d) are not breastfeeding. To confirm this, urine pregnancy tests will be repeated every month after screening. Women will be provided a full explanation of the potential dangers of pregnancy while taking MAS-XR. If a woman becomes pregnant, she will be taken off medication and continue standard treatment. At the end of the study, patients will be offered treatment until an appropriate referral can be made to a community clinic.

You may not qualify if:

• Individuals meeting DSM-5 criteria for schizophrenia, schizoaffective illness, psychotic disorder other than transient psychosis due to drug abuse, current major depression, bipolar illness or psychiatric disorders (other than substance abuse) which require psychiatric intervention or would interfere with study participation
• Individuals who are medically unstable based on laboratory tests, electrocardiogram, medical history, physical examination that would make participation hazardous
• Use of synthetic cannabinoids in the past month and meeting CUD diagnosis based on synthetic cannabinoids use alone in the past year
• Individuals with liver enzyme function tests greater than 3 times normal
• Individuals with significant current suicidal risk
• Individuals with systolic blood pressure \> 140; diastolic blood pressure \>90; pulse \>100
• Individuals who are cognitively impaired to impede study participation
• Nursing mothers and pregnant women
• Individuals who are physiologically dependent on any other drugs (excluding nicotine) that would require a medical intervention
• Individuals with known sensitivity/allergy to MAS-XR or amphetamine analogs
• Individuals currently being prescribed psychotropic medication (including sleep medication)
• Individuals with history of seizures
• Individuals who are mandated to treatment
• Individuals with a history of amphetamine use disorders, including amphetamines such as methamphetamine and methylenedioxymethamphetamine (MDMA).
• Individuals with a current cocaine use disorder

Sponsors & Collaborators

• New York State Psychiatric Institute: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

New York Psychiatric Institute

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

SLI381

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Results Point of Contact

• Title: Frances R Levin, MD
• Organization: New York State Psychiatric Institute

frl2@cumc.columbia.edu

6467746137

Study Officials

• Frances R Levin, MD

  New York Psychiatric Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Psychiatrist

Study Record Dates

• First Submitted: June 9, 2016
• First Posted: June 16, 2016
• Study Start: July 1, 2016
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: April 9, 2021
• Results First Posted: April 9, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)